Medical device industry under the microscopeIt’s possible that medtech insiders will remember 2018 as the year that their industry came under increased scrutiny. The documentary “The Bleeding Edge” on Netflix and the International Consortium of Investigative Journalists’ “Implant Files” report both raked the medical device industry, regulators and health providers over the coals for potentially overlooking serious problems.
“Bleeding Edge” included stories from people who had suffered injuries and/or illnesses following implantation of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh and various manufacturers’ metal artificial hips.
The ICIJ team poured over 8 million device-related health records – including more than 5.4 million adverse event reports filed with the FDA over the past 10 years. They found 1.7 million injuries and roughly 83,000 deaths potentially related to medical devices.
ICIJ investigators wrote that their report revealed a “fiercely competitive industry that has repeatedly run afoul of global law enforcement, financial and health authorities, and has used its formidable lobbying clout to pressure regulators to speed approvals and lower safety standards.”
They questioned why less than a twentieth devices that the FDA reviews go through more exhaustive and extreme premarket approval process – while many go through a 510(k) clearance that was initially meant only for incremental improvements.
The ICIJ series mentioned Medtronic multiple times and even focused in on the company’s diabetes unit and its insulin pumps.
Medtronic officials responded that the report was misleading because it didn’t adequately take into account the value that people with health problems receive from new medical device therapies.
Wall Street analyst Larry Biegelsen of Wells Fargo called the Implant Files a “negative news campaign” that “does not break any new ground and mainly rehashes known safety issues.”
Still, the reports appear to have had some success when it comes to rounding up all negative news reported in recent years (including by MassDevice and Medical Design & Outsourcing) and focusing on specific issues such as the 510(k) clearance process.
FDA has been responding. The agency, for example, came out with 510(k) modernization plans in late 2018. Proposals include moving away from predicate devices that are over a decade old and creating a new alternative 510(k) pathway.
Expect more industry scrutiny and regulatory reform proposals this year.